08:20 AM EDT, 09/09/2024 (MT Newswires) -- Rezolute ( RZLT ) said Monday that the US Food and Drug Administration has removed partial clinical holds on ersodetug or RZ358, the biotech firm's drug candidate to treat hypoglycemia caused by congenital hyperinsulinism.

The company said it will soon begin startup activities in the US for a global phase 3 study, with enrollment expected in early 2025.

Rezolute ( RZLT ) said it expects to release topline data from the study in the second half of 2025.

Shares of Rezolute ( RZLT ) were up more than 12% in recent premarket activity.

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